Paves Path for Application to FDA for Emergency Use Authorization before end of April 2020; Company providing high-throughput RNA-extraction robotics and enhanced-sensitivity RT-qPCR assay with goals to diminish false negatives, quantify viral loads and enhance testing volumes for the region.
Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) today announced the signing of an Agreement with Stony Brook University Hospital (the “Hospital”) to validate and implement the Company’s patent-pending nucleic acid diagnostic (LineaCOVID-19TM) to detect and quantify in diagnostic samples the presence of SARS-CoV-2, the virus that causes the disease, COVID-19. Validation is expected to begin immediately with results to be used to support the Company’s application to the U.S. Food and Drug Administration (FDA) before the end of April 2020 for Emergency Use Authorization (EUA).
“Built upon our work to develop COVID-19 vaccine candidates, we believe we have developed a high-sensitivity, high-throughput diagnostic that is urgently needed to meet the mass testing requirements of not just New York State, but also across the U.S. and the world. Working together with a local partner that is world-class medical institution, we are now at the final step of our diagnostic kit development program before moving to seek Emergency Use Authorization from the FDA,” stated Dr. James Hayward, president and CEO of Applied DNA. “We are very encouraged by our internal testing results to-date. We aligned 74 variants of the S-gene sequence currently available in the NCBI (National Center for Biotechnology Information) database. This gene is highly conserved, being close to 100% (99.97%) identical across variants; meaning that detection via our diagnostic kit should be consistent even against the capacity for this virus to mutate.”
Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA and a 30-year veteran of the RNA-based molecular diagnostics industry, stated, “We are pleased to be donating state-of -the-art robotics and diagnostic devices and integrating them into the Hospital’s facilities with the objective of yielding throughputs of more than 500 patient samples per 8-hour shift, with expected enhanced sensitivity and fewer false negatives. Our scientists and the Hospital are collaborating closely to dramatically increase throughput and sensitivity to better protect first responders and patients, and to enable comprehensive testing to the residents of Long Island.”
Yuhua Sun, Director of Applied Genomics at Applied DNA, and one of the developers of the assay, stated, “By teaming with our neighboring world-class hospital, we have mobilized with great speed, not only in development of the diagnostic, but in the continued exploration of viral loads in novel fluids and tissue samples to learn more about the course of this disease and the potential to improve diagnostics and therapeutics.”
The Agreement calls for Applied DNA to permanently contribute equipment to the Hospital who will act as third-party validator of the Company’s LineaCOVID-19 diagnostic, and for the Company to sell diagnostics kits to the Hospital once the EUA has been granted by FDA. Two forms of the diagnostic kit will be available to the market, a “Basic Kit” designed for high-volume labs that can provide some of the bulk ingredients usually found in large reserves at labs routinely processing thousands of patient samples per day, and a “Premium Kit” for labs that need everything at their fingertips. In addition, the Company is working with its vendors to provide a fully integrated monobloc platform that will allow certified testing organizations to install turnkey operations in a single order.
The Company plans to manufacture the positive controls (that confirm the test is operating properly) using its LinearDNA™ platform used recently to deliver quantities of five candidate linear DNA vaccines designed by its development partner in Italy, Takis Biotech. The LineaCOVID-19 diagnostic leverages the Company’s established knowhow regarding the Spike protein that is abundant on the surface of the virus. The Company believes the abundance of messenger RNA encoding for Spike is one of the factors that enhance the sensitivity of the assay. A provisional patent application has been filed with the United States Patent and Trademark Office (USPTO) protecting the concepts on which the assay is based.
Applied DNA makes clear that while the Company expects to file an EUA with the U.S. FDA by the end of the month, the U.S. FDA has not yet approved the Company’s diagnostic and there is no guarantee that any EUA will be approved.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.